TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS

Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Study ID
NCT06625450
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

All the trials using tofacitinib for maintenance of remission in UC have allowed the use of concomitant therapies except glucocorticoids. Mesalamine, a drug used in mild-to-moderate UC is often continued in patients receiving other drugs for maintenance. In this study, we plan to compare the effect of withdrawing mesalamine and continuing monotherapy with tofacitinib versus continuing dual therapy with tofacitinib and mesalamine. We hypothesize that the continuation of tofacitinib monotherapy after withdrawing mesalamine will be as efficacious and safe as continuation of the combination in remission maintenance in UC.

Key Dates

Start date
Oct 31, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tofacitinib
    Mesalamine will be withdrawn while tofacitinib will be continued during maintenance of remission of the disease
  • Active Comparator: Tofacitinib plus mesalamine
    Both mesalamine and tofacitinib will be continued during maintenance of remission of the disease

Primary Outcome Measure

Time to relapse of colitis [ Time Frame: 12 months ]

Central Contacts

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